CRA II

Fortrea; Warszawa; On-site; PLN 120,000 - 180,000; Full time

Job summary

Fortrea is seeking a CRA II for permanent, full-time work in Central or Southern Poland. The role covers site monitoring, regulatory compliance, data integrity, and QA activities across oncology studies.

You will conduct pre-study and initiation visits, oversee data collection, and ensure SAE reporting is accurate and timely. Candidates should have a life science or nursing background with at least 1.5 years of monitoring experience and be fluent in English and Polish.

Qualifications

• University graduate with a life science degree or nursing background.
• You relish fast-paced environments and complex, demanding protocols.
• Minimum 1.5 years of independent monitoring experience in international Pharma/CRO.
• Willing to work on Oncology studies; Oncology experience is a plus.
• Experience in interventional studies.
• Excellent understanding of Serious Adverse Event (SAE) reporting.
• Fluent in English and Polish.

Responsibilities

• Monitor study sites, conduct routine monitoring and close-out visits, and maintain study files.
• Liaise with vendors and manage site-related tasks as per the project plan.
• Ensure proper informed consent procedures and protocol adherence.
• Review CRFs and other data collection tools for data integrity.
• Track SAE reporting and prepare narratives and follow-up actions.
• Coordinate project activities as Local Project Coordinator and support client communications.

Skills

Independent monitoring

Oncology experience

SAE reporting

Education

Life science or nursing degree

Job description

We are currently recruiting for our multisponsor team in Central or Southern Poland and are looking to hire a permanent, full-time CRA II .Our positions offer excellent exposure to a range of disease areas, and a real opportunity for career progression and promotion in time.Responsibilities include but are not limited to:Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assignedResponsible for all aspects of site management as prescribed in the project planEnsure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the studyEnsure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirementsEnsure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document reviewMonitor data for missing or implausible dataEnsure the resources of the Sponsor and Fortrea are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelinesEnsure audit readiness at the site levelPrepare accurate and timely trip reportsResponsible for all aspects of registry management as prescribed in the project plansUndertake feasibility work when requestedParticipate in and follow up on Quality Control Visits (QC) when requestedRecruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisorMight be requested to work in a client facing environmentTrack and follow up on Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEIndependently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by managementAssist with training, of new employees, e.g. co-monitoringCoordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assignedEducation and Qualifications:We are searching for a university graduate with a life science degree or nursing background who relishes working in a fast paced environment, on complex and demanding protocols.If you are someone who is eager to constantly develop and improve while working in a friendly and collaborative team environment; then we are looking forward to meeting you.Minimum 1,5 years of independent monitoring experience in international Pharma/CRO companyExperience in Oncology preferred but not a must; although you should be willing to work on Oncology studiesExperience in interventional studiesExcellent understanding of Serious Adverse Event (SAE) reportingFluent in English and PolishLearn more about our EEO & Accommodations request here .